Regulatory Manager

About the Role The Regulatory Manager will provide regulatory oversight and operational support for a diverse portfolio of clinical research studies within the Heart Failure and New York Presbyterian Heart Failure Research Institute, ensuring compliance and serving as a liaison with IRB, sponsors, and institutional offices. What You'll Do

• Prepare and submit initial IRB applications, amendments, continuing reviews/renewals, and other required regulatory submissions
• Prepare submissions to oversight committees such as the Joint Radiation Safety Committee (JRSC) and other local review bodies
• Maintain comprehensive regulatory files and audit-ready documentation for all active protocols
• Monitor consent documentation and approval timelines to ensure compliance with human subject protection policies; prepare informed consent forms and related regulatory documents
• Conduct routine internal audits of regulatory files to ensure ongoing compliance
• Serve as primary liaison between investigators, the IRB, Clinical Trials Office, sponsors, CROs, and other institutional departments
• Support protocol start-up, maintenance, monitoring visits, investigator meetings, and study close-out activities
• Prepare and update regulatory documentation required for site initiation and monitoring visits
• Provide cost estimates related to radiation, anesthesiology, and other protocol-specific requirements as needed
• Work collaboratively with clinical, laboratory, and research staff to support study implementation
• Train study staff on regulatory requirements and maintenance of regulatory documentation
• Supervise and/or mentor regulatory support staff or coordinators, as applicable
• Participate in research-related meetings and provide regulatory expertise
• Perform additional administrative and research-related duties as assigned What We're Looking For
• Bachelor's degree or equivalent in education and experience, plus 4 years of related or relevant regulatory experience in clinical research
• Knowledge of clinical research regulatory requirements and human subject protection policies
• Experience with IRB submissions, regulatory document maintenance, and audit preparedness
• Proficiency with computer systems and electronic regulatory platforms
• Prior experience supporting investigator-initiated, and industry-sponsored clinical trials preferred
• Excellent writing, communication, and organizational skills; strong attention to detail; ability to work independently and interact effectively with staff at all levels
• Must successfully complete applicable compliance and systems training requirements Nice to Have
• Knowledge of clinical research regulatory requirements and human subject protection policies
• Experience with IRB submissions and audit readiness
• Proficiency with electronic regulatory platforms
• Prior experience supporting investigator-initiated and industry-sponsored trials Compensation & Benefits
• Salary Range: $74,500 - $79,500 annually